J.A. Belardi (Jorge)http://repub.eur.nl/ppl/571/
List of Publicationsenhttp://repub.eur.nl/eur_signature.pnghttp://repub.eur.nl/
RePub, Erasmus University RepositoryPerformance of the resolute zotarolimus-eluting stent in small vesselshttp://repub.eur.nl/pub/64216/
Tue, 01 Jul 2014 00:00:01 GMT<div>S. Caputo</div><div>M.B. Leon</div><div>P.W.J.C. Serruys</div><div>F.J. Neumann</div><div>A.C. Yeung</div><div>S. Windecker</div><div>J.A. Belardi</div><div>S. Silber</div><div>I. Meredith</div><div>P. Widimsky</div><div>S. Saito</div><div>L. Mauri</div>
Background Drug eluting stents for the treatment of small vessel coronary artery disease have traditionally yielded inferior clinical outcomes compared to the use of DES in large vessels. The benefit of the second-generation Resolute zotarolimus-eluting stent (R-ZES) in small vessels was examined. Methods Two-year clinical outcomes from five combined R-ZES studies were compared between patients with small (reference vessel diameter [RVD] ≤2.5 mm; n = 1,956) and large (RVD >2.5 mm; n = 3174) vessels. Results Despite a higher incidence of comorbidities in the small vessel group, there was no significant difference in target lesion failure (TLF) (10.1% vs. 8.7%; P = 0.54) at 2 years. When the subgroup of patients with diabetes was examined (n = 1,553) there was no significant difference in 2-year TLF in small compared to large vessels (11.2% vs. 11.1%; P = 0.17). Similarly, within the small vessel cohort, no significant difference was seen regarding TLF at 2 years between people with and without diabetes (11.2% vs 9.6%; P = 0.28). Conclusion When used for the treatment of small vessels, the R-ZES appears to provide acceptable clinical results at 2 years when compared to its performance in large vessels.Long-term outcomes of patients receiving zotarolimus-eluting stents in ST elevation myocardial infarction, non-ST elevation acute coronary syndrome, and stable angina: Data from the Resolute programhttp://repub.eur.nl/pub/62309/
Wed, 09 Oct 2013 00:00:01 GMT<div>P. Widimsky</div><div>Z. Motovska</div><div>J.A. Belardi</div><div>P.W.J.C. Serruys</div><div>S. Silber</div><div>S. Windecker</div><div>F.J. Neumann</div>
Background Outcome data are limited in patients with ST-segment elevation acute myocardial infarction (STEMI) or other acute coronary syndromes (ACSs) who receive a drug-eluting stent (DES). Data suggest that first generation DES is associated with an increased risk of stent thrombosis when used in STEMI. Whether this observation persists with newer generation DES is unknown. The study objective was to analyze the two-year safety and effectiveness of Resolute™ zotarolimus-eluting stents (R-ZESs) implanted for STEMI, ACS without ST segment elevation (non-STEACS), and stable angina (SA). Methods Data from the Resolute program (Resolute All Comers and Resolute International) were pooled and patients with R-ZES implantation were categorized by indication: STEMI (n = 335), non-STEACS (n = 1416), and SA (n = 1260). Results Mean age was 59.8 ± 11.3 years (STEMI), 63.8 ± 11.6 (non-STEACS), and 64.9 ± 10.1 (SA). Fewer STEMI patients had diabetes (19.1% vs. 28.5% vs. 29.2%; P < 0.001), prior MI (11.3% vs. 27.2% vs. 29.4%; P < 0.001), or previous revascularization (11.3% vs. 27.9% vs. 37.6%; P < 0.001). Two-year definite/probable stent thrombosis occurred in 2.4% (STEMI), 1.2% (non-STEACS) and 1.1% (SA) of patients with late/very late stent thrombosis (days 31-720) rates of 0.6% (STEMI and non-STEACS) and 0.4% (SA) (P = NS). The two-year mortality rate was 2.1% (STEMI), 4.8% (non-STEACS) and 3.7% (SA) (P = NS). Death or target vessel re-infarction occurred in 3.9% (STEMI), 8.7% (non-STEACS) and 7.3% (SA) (P = 0.012). Conclusion R-ZES in STEMI and in other clinical presentations is effective and safe. Long term outcomes are favorable with an extremely rare incidence of late and very late stent thrombosis following R-ZES implantation across indications.Clinical outcomes of the resolute zotarolimus-eluting stent in patients with in-stent restenosis: 2-year results from a pooled analysishttp://repub.eur.nl/pub/41624/
Sun, 01 Sep 2013 00:00:01 GMT<div>G. Richard</div><div>M. Leschke</div><div>M. Abdel-Wahab</div><div>R. Toelg</div><div>M. El-Mawardy</div><div>P.W.J.C. Serruys</div><div>S. Silber</div><div>S. Windecker</div><div>J.A. Belardi</div><div>F.J. Neumann</div><div>P. Widimsky</div>
Objectives This study sought to assess the clinical safety and effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) in patients with in-stent restenosis (ISR) from 2 large trials. Background ISR treatment is associated with higher rates of subsequent cardiac events compared with treatment of de novo lesions. Although drug-eluting stents (DES) are an option, second-generation DES are largely untested in the treatment of ISR. Methods A total of 3,489 patients were pooled from the RAC (RESOLUTE All Comers) trial and the RESOLUTE International (RINT) registry. Two-year clinical endpoints included clinically driven target lesion revascularization (TLR), target lesion failure (TLF), cardiac death (CD), target vessel myocardial infarction (TVMI), combined CD or TVMI (CD/TVMI), and Academic Research Consortium definite and probable stent thrombosis (ST). Results Overall, 281 patients (8.1%) received an R-ZES for ISR. Two-year TLR and TLF rates were significantly higher in ISR patients than in non-ISR patients (TLR: 12.7% vs. 4.3%, p = 0.003; TLF: 17.4% vs. 9.4%, p = 0.007); however, the CD/TVMI rate was not (6.9% vs. 6.1%, p = 0.711). Seven ISR patients had ST. Two-year outcomes by ISR stent type were similar: bare-metal stent (BMS)-ISR TLR was 12.5% and TLF was 17.2%; DES-ISR TLR was 13.0% and TLF was 18.8%. CD/TVMI was 7.3% and 7.2% for BMS-ISR and DES-ISR, respectively. Conclusions Using R-ZES to treat ISR appears equally safe in BMS-ISR and DES-ISR, with CD/TVMI rates comparable to 2-year outcomes in other clinical trials. Although revascularization rates are still higher in ISR lesions, the R-ZES offers an effective alternative for treatment of BMS-ISR and DES-ISR. (Randomized, Two-Arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent [RESOLUTE-AC]; NCT00617084; and RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population [RINT]; NCT00752128). Impact of Overlapping newer generation drug-eluting stents on clinical and angiographic outcomes: Pooled analysis of five trials from the international Global Resolute Programhttp://repub.eur.nl/pub/39926/
Wed, 01 May 2013 00:00:01 GMT<div>V. Farooq</div><div>P. Vranckx</div><div>L. Mauri</div><div>D.E. Cutlip</div><div>J.A. Belardi</div><div>S. Silber</div><div>P. Widimsky</div><div>M.B. Leon</div><div>S. Windecker</div><div>I. Meredith</div><div>M. Negoita</div><div>A.F. van Leeuwen</div><div>F.J. Neumann</div><div>A.C. Yeung</div><div>H.M. Garcia-Garcia</div><div>P.W.J.C. Serruys</div>
Background: Overlapping first generation sirolimus-and paclitaxel-eluting stents are associated with persistent inflammation, fibrin deposition and delayed endothelialisation in preclinical models, and adverse angiographic and clinical outcomes-including death and myocardial infarction (MI)-in clinical studies. Objectives: To establish as to whether there are any safety concerns with newer generation drug-eluting stents (DES). Design: Propensity score adjustment of baseline anatomical and clinical characteristics were used to compare clinical outcomes (Kaplan-Meier estimates) between patients implanted with overlapping DES (Resolute zotarolimus-eluting stent (R-ZES) or R-ZES/other DES) against no overlapping DES. Additionally, angiographic outcomes for overlapping R-ZES and everolimus-eluting stents were evaluated in the randomised RESOLUTE All-Comers Trial. Setting: Patient level data from five controlled studies of the RESOLUTE Global Clinical Program evaluating the R-ZES were pooled. Enrolment criteria were generally unrestrictive. Patients:5130 patients. Main outcome measures:2-year clinical outcomes and 13-month angiographic outcomes. Results:644 of 5130 patients (12.6%) in the RESOLUTE Global Clinical Program underwent overlapping DES implantation. Implantation of overlapping DES was associated with an increased frequency of MI and more complex/calcified lesion types at baseline. Adjusted in-hospital, 30-day and 2-year clinical outcomes indicated comparable cardiac death (2-year overlap vs non-overlap:3.0% vs 2.1%, p=0.36), major adverse cardiac events (13.3% vs 10.7%, p=0.19), target-vessel MI (3.9% vs 3.4%, p=0.40), clinically driven target vessel revascularisation (7.7% vs 6.5%, p=0.32), and definite/probable stent thrombosis (1.4% vs 0.9%, p=0.28). 13-month adjusted angiographic outcomes were comparable between overlapping and non-overlapping DES. Conclusions: Overlapping newer generation DES are safe and effective, with comparable angiographic and clinical outcomes-including repeat revascularisation-to non-overlapping DES.Clinical Outcome of Patients With and Without Diabetes Mellitus After Percutaneous Coronary Intervention With the Resolute Zotarolimus-Eluting Stent. 2-Year Results From the Prospectively Pooled Analysis of the International Global RESOLUTE Programhttp://repub.eur.nl/pub/39448/
Thu, 21 Mar 2013 00:00:01 GMT<div>S. Silber</div><div>P.W.J.C. Serruys</div><div>M.B. Leon</div><div>I. Meredith</div><div>S. Windecker</div><div>F.J. Neumann</div><div>J.A. Belardi</div><div>P. Widimsky</div><div>J. Massaro</div><div>V. Novack</div><div>A.C. Yeung</div><div>S. Saito</div><div>L. Mauri</div>
Objectives: The aim of this study was to describe the process to obtain Food and Drug Administration (FDA) approval for the expanded indication for treatment with the Resolute zotarolimus-eluting stent (R-ZES) in patients with coronary artery disease and diabetes. Background: The R-ZES is the first drug-eluting stent specifically indicated in the United States for percutaneous coronary intervention in patients with diabetes. Methods: We pooled patient-level data for 5,130 patients from the RESOLUTE Global Clinical Program. A performance goal prospectively determined in conjunction with the FDA was established as a rate of target vessel failure at 12 months of 14.5%. In addition to the FDA pre-specified cohort of less complex patients with diabetes (n = 878), we evaluated outcomes of the R-ZES in all 1,535 patients with diabetes compared with all 3,595 patients without diabetes at 2 years. Results: The 12-month rate of target vessel failure in the pre-specified diabetic cohort was 7.8% (upper 95% confidence interval: 9.51%), significantly lower than the performance goal of 14.5% (p < 0.001). After 2 years, the cumulative incidence of target lesion failure in patients with non-insulin-treated diabetes was comparable to that of patients without diabetes (8.0% vs. 7.1%). The higher risk insulin-treated population demonstrated a significantly higher target lesion failure rate (13.7%). In the whole population, including complex patients, rates of stent thrombosis were not significantly different between patients with and without diabetes (1.2% vs. 0.8%). Conclusions: The R-ZES is safe and effective in patients with diabetes. Long-term clinical data of patients with non-insulin-treated diabetes are equivalent to patients without diabetes. Patients with insulin-treated diabetes remain a higher risk subset. (The Clinical Response Evaluation of the Medtronic Endeavor CR ABT-578 Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions; NCT00248079; RESOLUTE All-comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention; NCT00617084; A Clinical Evaluation of the Medtronic Resolute Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries With a Reference Vessel Diameter of 2.25 mm to 4.2 mm; NCT00726453; RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population; NCT00752128; The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent in De Novo Lesions in Native Coronary Arteries; NCT00927940).The effect of variable dose and release kinetics on neointimal hyperplasia using a novel paclitaxel-eluting stent platform: The Paclitaxel In-Stent Controlled Elution Study (PISCES)http://repub.eur.nl/pub/55115/
Tue, 19 Jul 2005 00:00:01 GMT<div>P.W.J.C. Serruys</div><div>G. Sianos</div><div>A.C. Abizaid</div><div>J. Aoki</div><div>P. den Heijer</div><div>J.J.R.M. Bonnier</div><div>P.C. Smits</div><div>D. McClean</div><div>S. Verheye</div><div>J.A. Belardi</div><div>J. Condado</div><div>M. Pieper</div><div>L. Gambone</div><div>M. Bressers</div><div>J. Symons</div><div>E. Sousa</div><div>F. Litvack</div>
OBJECTIVES: The aim of this study was to evaluate the effect of variable dose and release kinetics of paclitaxel on neointimal hyperplasia. BACKGROUND: Conventional paclitaxel-eluting stents use a durable polymer coating as a vehicle for drug delivery. The Conor stent (Conor Medsystems, Menlo Park, California) with intra-strut wells and erodable polymer is specifically designed for drug delivery with programmable pharmacokinetics. METHODS: Two hundred and forty-four patients with single vessel disease received either a bare metal Conor stent (n = 53) or one of six different release formulations that varied in dose (10 or 30 μg) and elution release kinetics (first order, zero order), direction (abluminal, luminal), and duration (5, 10, and 30 days). End points at six months (bare stent group) and at four months (eluting stent groups) were angiographic late loss and neointimal tissue volume by intravascular ultrasound and the rate of major adverse cardiac events (MACE). RESULTS: The lowest in-stent late loss (0.38 mm, p <0.01, and 0.30 mm, p <0.01) and volume obstruction (8%, p <0.01, and 5%, p <0.01) were observed with the 10-μg and 30-μg doses in the 30-day release groups respectively, whereas the highest in-stent late loss (0.88 mm), volume obstruction (26%), and restenosis rate (11.6%) were observed in the bare stent group. The overall MACE rate of the eluting stent group was 8.6%: death 0.5%, myocardial infarction 2.7%, and target lesion revascularization (TLR) 5.3%. Sub-acute thrombosis was 0.5%. The TLR rates in the two 30-day release groups were 0% and 3.4%. CONCLUSIONS: This novel eluting stent platform, using an erodable polymer with complete elution of low doses of paclitaxel, is safe. The inhibition of the in-stent neointimal hyperplasia was best in the long release groups.Chronic arterial responses to polymer-controlled paclitaxel-eluting stents: comparison with bare metal stents by serial intravascular ultrasound analyses: data from the randomized TAXUS-II trial.http://repub.eur.nl/pub/13278/
Tue, 20 Jan 2004 00:00:01 GMT<div>K. Tanabe</div><div>P.W.J.C. Serruys</div><div>M. Degertekin</div><div>G. Guagliumi</div><div>E. Grube</div><div>C. Chan</div><div>T. Munzel</div><div>J.A. Belardi</div><div>W. Ruzyllo</div><div>L. Bilodeau</div><div>H. Kelbaek</div><div>J.A. Ormiston</div><div>K.D. Dawkins</div><div>L. Roy</div><div>B.H. Strauss</div><div>C. Disco</div><div>J. Koglin</div><div>M.E. Russell</div><div>A. Colombo</div>
BACKGROUND: Polymer-controlled paclitaxel-eluting stents have shown a pronounced reduction in neointimal hyperplasia compared with bare metal stents (BMS). The aim of this substudy was to evaluate local arterial responses through the use of serial quantitative intravascular ultrasound (IVUS) analyses in the TAXUS II trial. METHODS AND RESULTS: TAXUS II was a randomized, double-blind study with 536 patients in 2 consecutive cohorts comparing slow-release (SR; 131 patients) and moderate-release (MR; 135 patients) paclitaxel-eluting stents with BMS (270 patients). This IVUS substudy included patients treated with one study stent who underwent serial IVUS examination after the procedure and at 6-month follow-up (BMS, 152 patients; SR, 81; MR, 81). The analyzed stented segment (15 mm) was divided into 5 subsegments in which mean vessel area (VA), stent area (SA), lumen area (LA), intrastent neointimal hyperplasia area (NIHA), and peristent area (VA-SA) were measured. NIHA was significantly reduced in SR (0.7+/-0.9 mm2, P<0.001) and MR (0.6+/-0.8 mm2, P<0.001) compared with BMS (1.9+/-1.5 mm2), with no differences between the two paclitaxel-eluting release formulations. Longitudinal distribution of neointimal hyperplasia throughout the paclitaxel-eluting stent was uniform. Neointimal growth was independent of peristent area at postprocedure examination in all groups. There were progressive increases in peristent area from BMS to SR to MR (0.5+/-1.7, 1.0+/-1.8, and 1.4+/-2.0 mm2, respectively; P<0.001). The increase in peristent area was directly correlated with increases in VA. CONCLUSIONS: Both SR and MR paclitaxel-eluting stents prevent neointimal formation to the same degree compared with BMS. However, the difference in peristent remodeling suggests a release-dependent effect between SR and MR.Coronary flow velocity reserve after percutaneous interventions is predictive of periprocedural outcomehttp://repub.eur.nl/pub/66087/
Tue, 02 Apr 2002 00:00:01 GMT<div>M. Albertal</div><div>M. Voskuil</div><div>J.J. Piek</div><div>B. de Bruyne</div><div>G.J.J. van Langenhove</div><div>P.I. Kay</div><div>M.A. Costa</div><div>H. Boersma</div><div>T. Beijsterveldt</div><div>J.E. Sousa</div><div>J.A. Belardi</div><div>P.W.J.C. Serruys</div>
Coronary flow velocity reserve after percutaneous interventions is predictive of periprocedural outcomehttp://repub.eur.nl/pub/9882/
Tue, 01 Jan 2002 00:00:01 GMT<div>J.E. Sousa</div><div>J.A. Belardi</div><div>M. Voskuil</div><div>J.J. Piek</div><div>B. de Bruyne</div><div>G.J.J. van Langenhove</div><div>I.P. Kay</div><div>M.A. Costa</div><div>T. Beijsterveldt</div><div>P.W.J.C. Serruys</div><div>H. Boersma</div><div>M. Albertal</div>
BACKGROUND: Because heterogeneous results have been reported, we assessed coronary flow velocity changes in individuals who underwent percutaneous transluminal coronary angioplasty (PTCA) and examined their impact on clinical outcome. METHODS AND RESULTS: As part of the Doppler Endpoints Balloon Angioplasty Trial Europe (DEBATE) II study, 379 patients underwent Doppler flow-guided angioplasty. All patients were evaluated according to their coronary flow velocity reserve (CFVR) results (> or =2.5 or < 2.5) at the end of the procedure. A CFVR < 2.5 after angioplasty was associated with an elevated baseline blood flow velocity in both the target artery and reference artery. CFVR before PTCA and CFVR in the reference artery were independent predictors of an optimal CFVR after balloon angioplasty (CFVR before PTCA: odds ratio [OR], 2.26; 95% confidence interval [CI], 1.57 to 3.24; CFVR in reference artery: OR, 1.90; 95% CI, 1.21 to 2.98; both P<0.001) and stent implantation (before PTCA: OR, 2.54; 95% CI, 1.47 to 4.36; reference artery: OR, 1.97; 95% CI, 1.07 to 3.87; both P<0.05). A low CFVR at the end of the procedure was an independent predictor of major adverse cardiac events (MACE) at 30 days (OR, 4.71; 95% CI, 1.14 to 25.92; P=0.034) and at 1 year (OR, 2.06; 95% CI, 1.16 to 3.66; P=0.014). After excluding MACE at 30 days, no difference in MACE at 1 year was observed between the patients with and without a CFVR < 2.5 at the end of the procedure. CONCLUSIONS: A low postprocedural CFVR was associated with a worse periprocedural outcome (which was related to microcirculatory disturbances), but there was no significant difference at late follow-up.Continued benefit of coronary stenting versus balloon angioplasty: five-year clinical follow-up of Benestent-I trial.http://repub.eur.nl/pub/4835/
Thu, 10 May 2001 00:00:01 GMT<div>F. Kiemeneij</div><div>P.W.J.C. Serruys</div><div>C.M. Miguel</div><div>W.R. Rutsch</div><div>G.R. Heyndrickx</div><div>J. Fajadet</div><div>V.M.G. Legrand</div><div>P.H. Materne</div><div>J.A. Belardi</div><div>U. Sigwart</div><div>A. Colombo</div><div>J-J. Goy</div><div>C. Disco</div><div>M-A.M. Morel</div><div>P.A. Albertsson</div>
OBJECTIVES: This study sought to establish whether the early favorable results in the Benestent-I randomized trial comparing elective Palmaz-Schatz stent implantation with balloon angioplasty in 516 patients with stable angina pectoris are maintained at 5 years. BACKGROUND: The size of the required sample was based on a 40% reduction in clinical events in the stent group. Seven months and one-year follow-up in this trial showed a decreased incidence of restenosis and clinical events in patients randomized to stent implantation. METHODS: Data at five years were collected by outpatient visit, via telephone and via the referring cardiologist. Three patients in the stent group and one in the percutaneous transluminal coronary angioplasty (PTCA) group were lost to follow-up at five years. Major clinical events, anginal status and use of cardiac medication were recorded according to the intention to treat principle. RESULTS: No significant differences were found in anginal status and use of cardiac medication between the two groups. In the PTCA group, 27.3% of patients underwent target lesion revascularization (TLR) versus 17.2% of patients in the stent group (p = 0.008). No significant differences in mortality (5.9% vs. 3.1%), cerebrovascular accident (0.8% vs. 1.2%), myocardial infarction (9.4% vs. 6.3%) or coronary bypass surgery (11.7% vs. 9.8%) were found between the stent and PTCA groups, respectively. At five years, the event-free survival rate (59.8% vs. 65.6%; p = 0.20) between the stent and PTCA groups no longer achieved statistical significance. CONCLUSIONS: The original 10% absolute difference in TLR in favor of the stent group has remained unchanged at five years, emphasizing the long-term stability of the stented target site.Electrophysiologic characteristics in initiation of paroxysmal atrial fibrillation from a focal areahttp://repub.eur.nl/pub/55181/
Thu, 10 May 2001 00:00:01 GMT<div>F. Kiemeneij</div><div>P.W.J.C. Serruys</div><div>C.M. Miguel</div><div>W.R. Rutsch</div><div>G.R. Heyndrickx</div><div>P.A. Albertsson</div><div>J. Fajadet</div><div>V.M.G. Legrand</div><div>P.H. Materne</div><div>J.A. Belardi</div><div>U. Sigwart</div><div>A. Colombo</div><div>J-J. Goy</div><div>C. Disco</div><div>M-A.M. Morel</div>
OBJECTIVES: We investigated the electrophysiologic characteristics in the initiation of paroxysmal atrial fibrillation (PAF) from a focal area. BACKGROUND: The electrophysiologic characteristics in the initiation of PAF are still not clear. METHODS: The study group consisted of 77 patients (M/F = 65/12, age 66 ± 12 years) with frequent episodes of PAF; we analyzed: 1) 15 cycle lengths of electrical activity before the onset of atrial fibrillation (AF); 2) coupling interval (CI) of the first ectopic bear just before the initiation of AF; and 3) the prematurity of an ectopic beat (prematurity index [PI] = CI/mean of preceding 15 cycle lengths). RESULTS: A total of 111 episodes of sustained AF were identified. Two patterns of AF initiation were observed: group I (59/111, 53%) included the episodes preceded by cycle length oscillation, and group II (52/111, 47%) included the episodes initiated by a single ectopic beat with preceding cycle length relatively constant. The PI of group I episodes was significantly greater than that of group II (0.41 ± 0.12 vs. 0.34 ± 0.10, p < 0.01). The CI (267 ± 54 ms vs. 217 ± 55 ms, p < 0.05), AF1 (194 ± 36 ms vs. 153 ± 37 ms, p < 0.05) and PI (0.49 ± 0.13 vs. 0.37 ± 0.11, p < 0.01) of the AF episodes from the superior vena cava (SVC) were significantly longer and greater than those of AF episodes from pulmonary veins (PVs). CONCLUSIONS: In patients with PAF originating from PVs or the SVC, two major initiating patterns were found. Moreover, the electrophysiologic characteristics in the initiation of AF originating from the SVC were also different from those of AF initiating from the PVs.Uncomplicated moderate coronary artery dissections after balloon angioplasty: good outcome without stentinghttp://repub.eur.nl/pub/8301/
Mon, 01 Jan 2001 00:00:01 GMT<div>K. Kozuma</div><div>T. Beijsterveldt</div><div>S.G. Carlier</div><div>B. de Bruyne</div><div>J.A. Belardi</div><div>J.E. Sousa</div><div>G.J.J. van Langenhove</div><div>I.P. Kay</div><div>P.W.J.C. Serruys</div><div>D.P. Foley</div><div>E.S. Regar</div><div>G. Sianos</div><div>H. Boersma</div><div>M. Albertal</div>
OBJECTIVE: To study the relation between moderate coronary dissections, coronary flow velocity reserve (CFVR), and long term outcome. METHODS: 523 patients undergoing balloon angioplasty and sequential intracoronary Doppler measurements were examined as part of the DEBATE II trial (Doppler endpoints balloon angioplasty trial Europe). After successful balloon angioplasty, patients were randomised to stenting or no further treatment. Dissections were graded at the core laboratory by two observers and divided into four categories: none, mild (type A-B), moderate (type C), severe (types D to F). Patients with severe dissections (n = 128) or without available reference vessel CFVR (n = 139) were excluded. The remaining 256 patients were divided into two groups according to the presence (group A, n = 45) or absence (group B, n = 211) of moderate dissection. RESULTS: Following balloon angioplasty, there was no difference in CFVR between the two groups. At 12 months follow up, a higher rate of major adverse cardiac events was observed overall in group A than in group B (10 (22%) v 23 (11%), p = 0.041). However, the risk of major adverse events was similar in the subgroups receiving balloon angioplasty (group A, 6 (19%) v group B, 16 (16%), NS). Among group A patients, the adverse events risk was greater in those randomised to stenting (odds ratios 6.603 v 1.197, p = 0.046), whereas there was no difference in risk if the group was analysed according to whether the CFVR was < 2.5 or >/= 2.5 after balloon angioplasty. CONCLUSIONS: Moderate dissections left untreated result in no increased risk of major adverse cardiac events. Additional stenting does not improve the long term outcome.Randomized comparison of primary stenting and provisional balloon angioplasty guided by flow velocity measurement.http://repub.eur.nl/pub/9552/
Sat, 01 Jan 2000 00:00:01 GMT<div>N.H.J. Pijls</div><div>I. Simpson</div><div>O. Gurné</div><div>V. Voudris</div><div>B. de Bruyne</div><div>S.G. Carlier</div><div>B.A. van Hout</div><div>J.E. Sousa</div><div>G.A. van Es</div><div>J.J. Piek</div><div>T. Muramatsu</div><div>C. Vrints</div><div>J.A. Belardi</div><div>M-A.M. Morel</div><div>P. Probst</div><div>R. Seabra-Gomes</div><div>P.W.J.C. Serruys</div><div>H. Boersma</div>
BACKGROUND: Coronary stenting improves outcomes compared with balloon angioplasty, but it is costly and may have other disadvantages. Limiting stent use to patients with a suboptimal result after angioplasty (provisional angioplasty) may be as effective and less expensive. METHODS AND RESULTS: To analyze the cost-effectiveness of provisional angioplasty, patients scheduled for single-vessel angioplasty were first randomized to receive primary stenting (97 patients) or balloon angioplasty guided by Doppler flow velocity and angiography (523 patients). Patients in the latter group were further randomized after optimization to either additional stenting or termination of the procedure to further investigate what is "optimal." An optimal result was defined as a flow reserve >2.5 and a diameter stenosis <36%. Bailout stenting was needed in 129 patients (25%) who were randomized to balloon angioplasty, and an optimal result was obtained in 184 of the 523 patients (35%). There was no significant difference in event-free survival at 1 year between primary stenting (86.6%) and provisional angioplasty (85.6%). Costs after 1 year were significantly higher for provisional angioplasty (EUR 6573 versus EUR 5885; P:=0.014). Results after the second randomization showed that stenting was also more effective after optimal balloon angioplasty (1-year event free survival, 93.5% versus 84.1%; P:=0. 066). CONCLUSIONS: After 1 year of follow-up, provisional angioplasty was more expensive and without clinical benefit. The beneficial value of stenting is not limited to patients with a suboptimal result after balloon angioplasty.Heparin-coated Palmaz-Schatz Stents in Human Coronary Arteries. .http://repub.eur.nl/pub/5047/
Mon, 01 Jan 1996 00:00:01 GMT<div>P.W.J.C. Serruys</div><div>H.U. Emanuelsson</div><div>A.C. Lunn</div><div>F. Kiemeneij</div><div>C.M. Miguel</div><div>W.R. Rutsch</div><div>G.R. Heyndrickx</div><div>H. Suryapranata</div><div>V.M.G. Legrand</div><div>J-J. Goy</div><div>P.H. Materne</div><div>J.J.R.M. Bonnier</div><div>M-C. Morice</div><div>J. Fajadet</div><div>J.A. Belardi</div><div>A. Colombo</div><div>E. Garcia</div><div>P.N. Ruygrok</div><div>M-A.M. Morel</div><div>W.J. van der Giessen</div><div>P.P.T. de Jaegere</div>
Background The purpose of the Benestent-II Pilot Study was to evaluate the safety of delaying and eliminating anticoagulant therapy in patients receiving a heparin-coated stent in conjunction with antiplatelet drugs.
Methods and Results The study consisted of three initial phases (I, II, III) during which resumption of heparin therapy after sheath removal was progressively deferred by 6, 12, and 36 hours. In phase IV, coumadin and heparin were replaced by 250 mg ticlopidine and 100 mg aspirin. Of the 207 patients with stable angina pectoris and a de novo lesion in whom heparin-coated stent implantation was attempted, implantation was successful in 202 patients (98%). Stent thrombosis did not occur during all four phases, and the overall clinical success rate at discharge was 99%. Bleeding complications requiring blood transfusion or surgery fell from 7.9% in phase I to 5.9%, 4%, and 0% in the three following phases. Hospital stay was 7.4, 6.1, 7.2, and 3.1 days for the consecutive phases. The restenosis rate for the combined four phases was 13% (15% in phase I, 20% in phase II, 11% in phase III, and 6% in phase IV). The overall rate of reintervention for the four phases was 8.9%. At 6 months, 84%, 75%, 94%, and 92% of the patients of phases I to IV, respectively, were event free. For the four phases, the event-free rate was 86%, which compares favorably with the rate observed in the Benestent-I study (80%; relative risk, 0.68 [0.45 to 1.04]).
Conclusions The implantation of stents coated with polyamine and end-point–attached heparin in stable patients with one significant de novo coronary lesion is well tolerated, is associated with no (sub)acute stent thrombosis, and results in a favorable event-free survival after 6 months.A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery diseasehttp://repub.eur.nl/pub/58398/
Thu, 25 Aug 1994 00:00:01 GMT<div>P.W.J.C. Serruys</div><div>P.P.T. de Jaegere</div><div>F. Kiemeneij</div><div>C.M. Miguel</div><div>W.R. Rutsch</div><div>G.R. Heyndrickx</div><div>H.U. Emanuelsson</div><div>J. Marco</div><div>V.M.G. Legrand</div><div>P.H. Materne</div><div>J.A. Belardi</div><div>U. Sigwart</div><div>A. Colombo</div><div>J-J. Goy</div><div>P.A. van den Heuvel</div><div>J. Delcan</div><div>M-A.M. Morel</div>
Balloon-expandable coronary-artery stents were developed to prevent coronary restenosis after coronary angioplasty. These devices hold coronary vessels open at sites that have been dilated. However, it is unknown whether stenting improves long-term angiographic and clinical outcomes as compared with standard balloon angioplasty.A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease.http://repub.eur.nl/pub/4616/
Sat, 01 Jan 1994 00:00:01 GMT<div>P.W.J.C. Serruys</div><div>P.P.T. de Jaegere</div><div>F. Kiemeneij</div><div>C.M. Miguel</div><div>W.R. Rutsch</div><div>G.R. Heyndrickx</div><div>H.U. Emanuelsson</div><div>J. Marco</div><div>V.M.G. Legrand</div><div>P.H. Materne</div><div>J.A. Belardi</div><div>U. Sigwart</div><div>A. Colombo</div><div>J-J. Goy</div><div>P. van den Heuvel</div><div>J. Delcan</div><div>M-A.M. Morel</div>
BACKGROUND. Balloon-expandable coronary-artery stents were developed to prevent coronary restenosis after coronary angioplasty. These devices hold coronary vessels open at sites that have been dilated. However, it is unknown whether stenting improves long-term angiographic and clinical outcomes as compared with standard balloon angioplasty. METHODS. A total of 520 patients with stable angina and a single coronary-artery lesion were randomly assigned to either stent implantation (262 patients) or standard balloon angioplasty (258 patients). The primary clinical end points were death, the occurrence of a cerebrovascular accident, myocardial infarction, the need for coronary-artery bypass surgery, or a second percutaneous intervention involving the previously treated lesion, either at the time of the initial procedure or during the subsequent seven months. The primary angiographic end point was the minimal luminal diameter at follow-up, as determined by quantitative coronary angiography. RESULTS. After exclusions, 52 patients in the stent group (20 percent) and 76 patients in the angioplasty group (30 percent) reached a primary clinical end point (relative risk, 0.68; 95 percent confidence interval, 0.50 to 0.92; P = 0.02). The difference in clinical-event rates was explained mainly by a reduced need for a second coronary angioplasty in the stent group (relative risk, 0.58; 95 percent confidence interval, 0.40 to 0.85; P = 0.005). The mean (+/- SD) minimal luminal diameters immediately after the procedure were 2.48 +/- 0.39 mm in the stent group and 2.05 +/- 0.33 mm in the angioplasty group; at follow-up, the diameters were 1.82 +/- 0.64 mm in the stent group and 1.73 +/- 0.55 mm in the angioplasty group (P = 0.09), which correspond to rates of restenosis (diameter of stenosis, > or = 50 percent) of 22 and 32 percent, respectively (P = 0.02). Peripheral vascular complications necessitating surgery, blood transfusion, or both were more frequent after stenting than after balloon angioplasty (13.5 vs. 3.1 percent, P < 0.001). The mean hospital stay was significantly longer in the stent group than in the angioplasty group (8.5 vs. 3.1 days, P < 0.001). CONCLUSIONS. Over seven months of follow-up, the clinical and angiographic outcomes were better in patients who received a stent than in those who received standard coronary angioplasty. However, this benefit was achieved at the cost of a significantly higher risk of vascular complications at the access site and a longer hospital stay.